PHARMACY

Diplomat’s move to Flint, Mich., featured in local news

BY Michael Johnsen

FLINT, Mich. The city of Flint soon will give rise to a new job-generating industry in the coming years: specialty pharmacy. Best known as the birthplace of GM, Flint, Mich., now will play host to the expanding Diplomat Specialty Pharmacy, which recently was featured in a WJRT news segment.

(Click here to see the video segment)

Diplomat’s new state-of-the-art headquarters facility, which stands at more than 340,000 sq. ft., is expected to open in Flint later this year, bringing more than 1,000 new jobs to the area over the next five years. Diplomat president and CEO Phil Hagerman expected the number of available positions at Diplomat to quadruple before 2030.

The pending growth within the specialty pharmacy sector will be driven from one of several factors, Hagerman told Drug Store News’ sister publication Specialty Pharmacy earlier this year. Growth opportunity by disease states include oncology, which is already Diplomat’s largest category of specialty business and accounts for almost half of the specialty pharmacy’s business today, Hagerman said. Diplomat also is a significant player within immune response (rheumatoid arthritis, dermatology and Crohn’s disease), the multiple sclerosis care community, HIV/AIDS, hepatitis C and growth hormone. There are other specialty pharmacy disease states that are within Diplomat’s care spectrum, Hagerman said, but these represent many of the faster growth areas.

Diplomat is the nation’s largest independently-owned-and-operated specialty pharmacy. Diplomat generated $380 million in revenue in 2009, according to Inc., ranking No. 55 on that publication’s list of top 100 growth companies as measured by gross dollars.

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J&J receives complete response letter for tapentadol ER

BY Alaric DeArment

RARITAN, N.J. The Food and Drug Administration turned down a regulatory approval application from Johnson & Johnson for a drug to treat chronic pain, J&J said Monday.

 

The drug maker said the FDA issued a complete response letter for tapentadol extended-release tablets. The agency is requesting data concerning the conversion of the extended-release formulation of the drug used in clinical trials to a different formulation designed to increase the drug’s resistance to breaking or crushing by drug abusers. The FDA issues a complete response letter when it needs more data before it can approve a drug.

 

 

“We will engage the FDA in active discussions as quickly as possible so that we can address the requests in the complete response letter,” Johnson & Johnson pharmaceutical research and development therapeutic area head for analgesia Juergen Haeussler said. “We remain fully committed to bringing tapentadol ER to patients experiencing chronic pain as quickly as possible.”

 

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NCPA to HHS: Ensure patients’ access to pharmacies, enforce transparency rules for PBMs

BY Alaric DeArment

ALEXANDRIA, Va. The lobby for the country’s independent pharmacies is urging the Department of Health and Human Services to ensure patients’ access to community pharmacies and enforce transparency rules for pharmacy benefit managers.

The National Community Pharmacists Association said Monday that it had asked HHS to adopt minimum pharmacy access standards in healthcare insurance exchanges. The NCPA also argued against tiered co-payments that favor one pharmacy provider, such as mail order, over others, and argued in favor of allowing any pharmacy willing to accept the terms of the pharmacy contract to participate.

The healthcare-reform law requires PBMs operating in the health-insurance exchanges to confidentially report such information as the percentage of all prescriptions provided through retail pharmacies compared with mail order, and the generic dispensing and substitution rates of each; the aggregate amount and types of rebates, discounts and price concessions that the PBM negotiates on behalf of the plan and the aggregate amount passed on to the plan sponsor; and the average aggregate difference between the amount the plan pays the PBM and the amount the PBM pays the retail and mail-order pharmacy.

“Access to this critical information will enable the [HHS secretary] and the health plans to better evaluate and, in turn, negotiate contracts for prescription drug benefit administration in order to contain costs and maximize consumer protections,” the NCPA said in its comments to HHS. “To date, there has been no clear direction as to where these new federal PBM discloser requirements should be included.”

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